单用拉米夫定与联合α干扰素治疗慢性乙型肝炎的疗效观察

Clinical evaluation of lamivudine alone or combined with inteferon alpha as antiviral therapy for patients with chronic hepatitis B

目的 观察和对比单用拉米夫定与拉米夫定联合α干扰素治疗慢性乙型肝炎的安全性和疗效。方法 拉米夫定组 6 4例 ,单服拉米夫定 ,10 0mg或 15 0mg ,每日 1次 ,其中 5 4例 ( 84.4% )用药超过 12个月。联合组 49例 ,拉米夫定用药 2周后加用干扰素 (甘乐能或罗荛愫 ) ,3MU～ 5MU肌肉或皮下注射 ,每周 3次 ,2 4周后停干扰素 ,继续服拉米夫定 ,其中 38例 ( 77.6 % )治疗超过 12个月。两组在治疗 6个月、12个月时分别进行疗效评价 ,并继续随访 4～ 2 6个月。结果 拉米夫定组和联合组 6个月时ALT/AST复常率分别为 90 .6 % /92 .2 %和 89.8% /93.9% (P >0 .0 5 ) ;HBVDNA阴转率分别为 96 .9%和 98.0 % (P >0 .0 5 ) ;HBeAg的血清转换率为 2 0 .3%和 2 8.6 % (P >0 .0 5 )。 12个月时两组ALT/AST的复常率分别为 90 .7% /90 .7和 89.5 % /92 .1% (P >0 .0 5 ) ;HBVDNA阴转率为 88.9%和 89.5 % (P >0 .0 5 ) ;HBeAg的血清转换率则分别为 31.5 % ( 17/5 4)和 5 5 .3% ( 2 1/38) ,P <0 .0 5。HBeAg的血清转换率似乎与治疗前的转氨酶水平较高、HBeAg和HBVDNA水平较低有关。治疗 9～ 2 4个月期间拉米夫定组 9例 ( 14 .1% )、联合组 6例 ( 12 .2 % )发生HBV多聚酶YMDD变异。结论 拉米夫定和干扰素联合治疗慢性乙型肝?

Objective To observe and evaluate the safety and efficacy of lamivudine alone or combined with interferon alpha as antiviral therapy for patients with chronic hepatitis B. Methods Sixty four patients were enrolled to receive lamivudine alone, 100mg or 150mg orally, once daily, 54 of whom(84.4%) being treated more than 12 months. Fourty nine patients were enrolled in the combination therapy group. Two weeks after lamivudine treatment, interferon alpha(Intron A or Referon A) was initiated, 3MIU～5MIU intramuscularly or subcutaneously, thrice a week for 24 weeks only, then lamivudine was administered continuously, 38 of whom(77.6%) being treated more than 12 months. All cases were evaluated periodically during the treatment and 4～26 months follow up.Results At month 6, the normalization rates of ALT/AST were 90.6%/92.2% in lamivudine group and 89.8%/93.9% in the combinaiton group, respectively( P >0.05), undetectable rates of serum HBV DNA and HBeAg seroconversion rates were 96.9% and 20.3% in lamivudine group, 98.0% and 28.6% in combination group, respectively( P >0.05). But at month 12, HBeAg seroconversion rates were 31.5%(17/54) in lamivudine group, 55.3 %(21/38) in combination group( P <0.05). It appeared that the rate of HBeAg seroconversion was associated with a higher ALT/AST level and a lower baseline of HBeAg, HBV DNA level. During continueing lamivudine treatment, 9 cases(14.1%) in lamivudine group and 6 cases(12.2%) in the combination group developed YMDD mutation of HBV polymerase.Conclusions The effectiveness and tolerability of combined interferon alpha and lamivudine, worth consideration as a promising antiviral strategy and more satisfactory than lamivudine alone in the treatment of chronic hepatitis B.